MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; PATELLA 26MM

Model Number	200-05-26
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): logic cr tib insert std, sz 2, 9mm (cat# 02-012-47-2009).
Event or Problem Description
As reported, average size female patient with dob of (b)(6) 1948 being revised due to patella pain in right knee.Removed the inset patella, recut the surface and placed a resurfacing 3 peg patella.Insert was not worn but surgeon chose to replace it while there with a similar thickness insert.Device will not return due to hospital policy all available information has been received.
Event or Problem Description
As reported, average size female patient with dob of (b)(6) 1948 being revised due to patella pain in right knee.Removed the inset patella, recut the surface and placed a resurfacing 3 peg patella.Insert was not worn but surgeon chose to replace it while there with a similar thickness insert.Device will not return due to hospital policy.Left the operating room, the patient was stable and doing well all available information has been received.
Additional Manufacturer Narrative
(h3) the evaluation noted that the devices were not returned and therefore, not evaluated.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the revision is most likely is related to the patient¿s underlying condition; due to the pain was reported and the patient¿s native patella was replaced.(d11) concomitant device(s): logic cr tib insert std, sz 2, 9mm (cat# 02-012-47-2009).

• Brand Name: OPTETRAK
• Common Device Name: PATELLA 26MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9353427
• Report Number: 1038671-2019-00578
• Device Sequence Number: 480200
• Product Code: JWH
• UDI-Device Identifier: 10885862039842
• UDI-Public: 10885862039842
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 200-05-26
• Device Catalogue Number: 200-05-26
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR